U.S. panel weighs risk of drug-coated heart stents Thu Dec 7, 2006 11:56 PM IST139 http://in.today.reuters.com/News/ne...34907Z_01_NOOTR_RTRJONC_0_India-279455-1.xml By Lisa Richwine GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel heard evidence on Thursday about risks of drug-coated stents, the tiny mesh tubes used to prop open arteries in millions of heart patients. A controversy erupted this year when research showed the devices may cause dangerous blood clots in some patients months after being implanted. Johnson & Johnson and Boston Scientific Corp. sell drug-coated stents in the United States. Hoping to guide doctors and patients, U.S. Food and Drug Administration officials turned to a panel of 21 outside experts for advice on whether the device's benefits outweigh the risks and if extended anti-clotting drug therapy should be recommended. They also sought input on whether safety concerns applied equally to stents made by both companies. Drug-coated stents were hailed as a major advance just three years ago because the drug coating cuts the chances of an artery closing again, a problem reported with about a quarter of bare-metal stents. Now, doctors are rethinking their quick adoption of drug-coated stents after blood clotting was seen in a small percentage of patients. Blood clots can kill or cause heart attacks. Data so far indicate a "small but significant" increase in blood clots a year or more after a drug-coated stent is placed, FDA reviewer Andrew Farb told the panel. However, "it has not been established" if that leads to an elevated risk of having a heart attack or dying, he said. Some panel members pressed Farb on why the clots had not been shown to increase those problems. "One explanation could be the numbers are too small to show a difference. We're talking about relatively rare events," he said. The FDA panel was scheduled to provide input on Thursday about the risks when drug-coated stents are placed according to instructions on their labels. But an estimated 60 percent or more of drug-coated stents are implanted in harder-to-treat patients who do not meet criteria for approved uses, FDA officials said. The panel will start discussing use in those patients late on Thursday and is set to give advice on that issue on Friday. Nearly 6 million patients worldwide have received drug-coated stents, and the market is worth nearly $6 billion a year, according to an estimate by JP Morgan analysts. Makers said the drug-coated versions offered advantages over bare-metal alternatives. Boston Scientific said it found a slight increase in blood clots with its Taxus drug-coated stent but no higher rate of heart attacks or deaths. "The things patients care about -- am I more likely to be dead or have a large heart attack -- the answer is 'no,'" said Boston Scientific Chief Medical and Scientific Officer Donald Baim. Johnson & Johnson said data so far show no significant difference between the risk of blood clots from its Cypher drug-coated stent and bare-metal versions. "Patients treated with the Cypher stent and bare-metal stents have a similar overall risk of stent (clotting) over four years," said Campbell Rogers, chief technology officer at Johnson & Johnson unit Cordis. Abbott Laboratories Inc. and Medtronic Inc. market their versions of drug-coated stents in other countries, and are aiming for U.S. launches as early as mid-2007.